MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED STEM, STRAIGHT, FLUTED, 13X120MM

Model Number	HC-13120-03M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of this event is in progress.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were reported for this event: 3013450937-2021-00235, 3013450937-2021-00236.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an unknown reason.A segmental stem was requested for the revision surgery but was not implanted.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient fell for an unknown reason which caused soft tissue damage to the surrounding structures of the knee.During the revision surgery, the surgeon performed a soft tissue repair.A segmental stem was requested for the revision surgery but was not implanted.No eleos implants were revised during the revision surgery.No additional information regarding this adverse event has been made available.
Additional Manufacturer Narrative
Additional information regarding this adverse event was received on (b)(6) 2021 and the investigation was concluded on (b)(6) 2021.The patient suffered a fall due to an unknown reason which caused soft tissue damage.The surgeon performed a soft tissue repair during the surgery and did not revise any of the eleos implants.The device was not returned for evaluation.The root cause of the patient's fall could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections have been updated: b4: date of this report added.B5: event description updated.G3: date received by manufacturer added.G6: type of report added.H2: follow up type added.H3: device evaluated by manufacturer updated to no.H6: clinical code updated to 1848: fall.H6: clinical code updated to 4559: unspecified tissue injury.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.Multiple mdr reports were submitted for this event: #3013450937-2021-00235.#3013450937-2021-00236.#3013450937-2021-00321.#3013450937-2021-00322.#3013450937-2021-00323.#3013450937-2021-00324.#3013450937-2021-00325.#3013450937-2021-00326.#3013450937-2021-00327.

• Brand Name: ELEOS
• Common Device Name: CEMENTED STEM, STRAIGHT, FLUTED, 13X120MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 12655974
• Report Number: 3013450937-2021-00234
• Device Sequence Number: 4298207
• Product Code: KRO
• UDI-Device Identifier: B278HC1312003M0
• UDI-Public: +B278HC1312003M0
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HC-13120-03M
• Device Catalogue Number: HC-13120-03M
• Device Lot Number: 84549-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001050E, ELEOS MALE-FEMALE MIDSECTION 50MM; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION 70MM; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N HR-30000-03M ELEOS MODULAR COLLAR LOCKING RING; P/N PB-2400R-03M, ELEOS BIOGRIP COLLAR; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT; P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001050E, ELEOS MALE-FEMALE MIDSECTION 50MM; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION 70MM; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N HR-30000-03M ELEOS MODULAR COLLAR LOCKING RING; P/N PB-2400R-03M, ELEOS BIOGRIP COLLAR; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male